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Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA

Primary Purpose

Knee Osteoarthritis, Hyaluronic Acid

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
JETKNEE Synovial Fluid Supplement
Normal saline
Sponsored by
SciVision Biotech Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age 45 to 85 years of male or female.
  2. Meet the ACR diagnostic criteria, the target knee is confirmed with OA by radiographic images and Kellgren &Lawrence (K-L) score of 2 to 3；
  3. Patients who still suffer from OA pain after receiving traditional non-drug therapy or general analgesic therapy within 6 months before the start of the study；
  4. The VAS pain score of target knee must be at least 3 cm within 1 week before the screening and if the other side of knee has OA at the same time, the VAS pain score should be less than 3 cm；
  5. Subject who has ability to understand the study purpose, comply with the study requirements, willing to stop all pain medications and physical therapy to the knees during the study and sign informed consent form (ICF).

Exclusion Criteria:

  1. The hip or ankle joints are diagnosed with OA, pain, or deformity；
  2. K-L score of 4 by radiographic image evaluation；
  3. The target knee has symptoms such as infection, redness, and swelling at the screening period and before treatment ；
  4. The target knee has received hyaluronic acid treatment within 6 months before included in the study；
  5. The target side has received lower limb surgery or knee operation with accompanied complications and significant mobility impairment within 6 months before the start of the study；
  6. The target knee has received treatments such as steroid injection, arthrocentesis or arthroscopic surgery within 3 months before screening；
  7. Patient with autoimmune disease (such as autoimmune collagenopathy, rheumatoid arthritis), malignant tumors, coagulation disorder, heart diseases, mental diseases…etc. which may cause higher risk to patients during participation in the study；
  8. Receiving orthopedic-related treatments which may affect the evaluation of the study；
  9. With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins；
  10. Pregnant, planning pregnancy or in breastfeeding females during the study period；
  11. Subject who cannot cooperate with the follow- ups；
  12. Other circumstances which judged to be unsuitable for participating in the study by the investigator.

Sites / Locations

  • Kaohsiung Municipal Siaogang Hospital
  • Kaohsiung Veterans General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mannitol-combined Hyaluronic acid

Normal saline

Arm Description

2.0mL/syringe for one treatment

2.0mL for one treatment

Outcomes

Primary Outcome Measures

The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.

Secondary Outcome Measures

The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment The WOMAC measures five items for pain (score range 0-20).Higher scores indicate worse pain, stiffness, and functional limitations.
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures two for stiffness (score range 0-8).Higher scores indicate worse pain, stiffness, and functional limitations.
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment

Full Information

First Posted
January 5, 2022
Last Updated
September 11, 2023
Sponsor
SciVision Biotech Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05201040
Brief Title
Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA
Official Title
A Prospective, Randomized, Evaluator/Subject-blinded, Double-Center, Controlled Clinical Study: Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SciVision Biotech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee osteoarthritis (OA).
Detailed Description
The medical device is a bioabsorbable, extensible, crosslinked, 2% hyaluronic acid gel using micro-organism fermentation sourced hyaluronic acid as a major component and add mannitol is added which can inhibit the degradation of hyaluronate acid by free radicals to prolong the therapeutic effect. The medical device is injected into the articular cavity to protect joint tissue, increase joint lubricity, inhibit degradation of cartilage and promote the metabolism of cartilage by infiltrating degenerated cartilage. In addition, the medical device can penetrate the synovial tissue to inhibit inflammation and degradation. It also inhibits pain mediators in the synovium to achieve the pain inhibition. This study is to evaluate the effectiveness and safety of JETKNEE Synovial Fluid Supplement for alleviating pain of knee OA 6 months after single injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Hyaluronic Acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mannitol-combined Hyaluronic acid
Arm Type
Experimental
Arm Description
2.0mL/syringe for one treatment
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
2.0mL for one treatment
Intervention Type
Device
Intervention Name(s)
JETKNEE Synovial Fluid Supplement
Intervention Description
2mL of JETKNEE Synovial Fluid Supplement
Intervention Type
Device
Intervention Name(s)
Normal saline
Intervention Description
2mL of normal saline
Primary Outcome Measure Information:
Title
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment.
Description
The pain score of Visual Analog Scale (VAS) of target knee at 6 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
Time Frame
6 months post-treatment
Secondary Outcome Measure Information:
Title
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment
Description
The pain score of VAS of target knee at baseline, 2 weeks, 1 month, and 3 months post-treatment. Based on the patient described pain intensity as 0 to 10 score, a higher score indicates greater pain intensity.
Time Frame
baseline, 2 weeks, 1 month, and 3 months post-treatment
Title
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
The average score of Western Ontario and McMaster Universities (WOMAC) in pain section of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment The WOMAC measures five items for pain (score range 0-20).Higher scores indicate worse pain, stiffness, and functional limitations.
Time Frame
baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
The average score of WOMAC in stiffness section of target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures two for stiffness (score range 0-8).Higher scores indicate worse pain, stiffness, and functional limitations.
Time Frame
baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
The average score of WOMAC in function section of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
Time Frame
baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
The average total score of WOMAC of the target knee at baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment. The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).Higher scores indicate worse pain, stiffness, and functional limitations.
Time Frame
baseline, 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
The average total score of Lequesne's Index (LI) of target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Time Frame
baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Description
The thickness of femoral Intercondylar cartilage of the target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Time Frame
baseline and1 month, 3 months and 6 months post-treatment
Title
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
Description
The quadriceps thickness of the target knee by ultrasound at baseline and 1 month, 3 months and 6 months post-treatment
Time Frame
baseline and 1 month, 3 months and 6 months post-treatment
Title
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Description
The grade of cartilage of target knee by ultrasound at baseline, 1 month, 3 months and 6 months post-treatment
Time Frame
baseline, 1 month, 3 months and 6 months post-treatment
Title
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
Holding time of Single-leg Stance Test (SLS) on target knee at baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Time Frame
baseline and 2 weeks, 1 month, 3 months and 6 months post-treatment
Title
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Description
Subject self-evaluating satisfaction at 2 weeks, 1 month, 3 months and 6 months post-treatment
Time Frame
2 weeks, 1 month, 3 months and 6 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 45 to 85 years of male or female. Meet the ACR diagnostic criteria, the target knee is confirmed with OA by radiographic images and Kellgren &Lawrence (K-L) score of 2 to 3； Patients who still suffer from OA pain after receiving traditional non-drug therapy or general analgesic therapy within 6 months before the start of the study； The VAS pain score of target knee must be at least 3 cm within 1 week before the screening and if the other side of knee has OA at the same time, the VAS pain score should be less than 3 cm； Subject who has ability to understand the study purpose, comply with the study requirements, willing to stop all pain medications and physical therapy to the knees during the study and sign informed consent form (ICF). Exclusion Criteria: The hip or ankle joints are diagnosed with OA, pain, or deformity； K-L score of 4 by radiographic image evaluation； The target knee has symptoms such as infection, redness, and swelling at the screening period and before treatment ； The target knee has received hyaluronic acid treatment within 6 months before included in the study； The target side has received lower limb surgery or knee operation with accompanied complications and significant mobility impairment within 6 months before the start of the study； The target knee has received treatments such as steroid injection, arthrocentesis or arthroscopic surgery within 3 months before screening； Patient with autoimmune disease (such as autoimmune collagenopathy, rheumatoid arthritis), malignant tumors, coagulation disorder, heart diseases, mental diseases…etc. which may cause higher risk to patients during participation in the study； Receiving orthopedic-related treatments which may affect the evaluation of the study； With history of hypersensitivity or allergy to hyaluronic acid or any component of the device; With history of hypersensitivity or allergy to Gram-positive bacteria or Streptococcus proteins； Pregnant, planning pregnancy or in breastfeeding females during the study period； Subject who cannot cooperate with the follow- ups； Other circumstances which judged to be unsuitable for participating in the study by the investigator.
Facility Information:
Facility Name
Kaohsiung Municipal Siaogang Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluate the Safety and Effectiveness of Mannitol-combined Hyaluronan Supplement in the Treatment of Knee OA

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